BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRAMINI METER

    MDR report key: 1658571 · Received April 9, 2010

    Report

    Report Number
    2939301-2010-02639
    Event Type
    Injury
    Date Received
    April 9, 2010
    Report Date
    March 10, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVAL. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PT FOR F/U QUESTIONS. THE MSS CLASSIFIED THIS COMPLAINT BASED ON CUSTOMER SERVICE REP (CSR) DOCUMENTATION. A LETTER HAS BEEN SENT TO THE PT REQUESTING A CALL BACK. THE LAY USER/PT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ALLEGING THAT THE ONE TOUCH ULTRAMINI METER WAS READING INACCURATELY CONTROL LOW. A CONTROL SOLUTION TEST RESULT OF 88 MG/DL WAS OBTAINED FOR A CONTROL RANGE OF 102 TO 137 MG/DL. THE ISSUE FIRST OCCURRED AT 6 PM PST. THE PT INDICATED THAT 30 MINUTES PRIOR TO PERFORMING A CONTROL SOLUTION TEST, HE DEVELOPED SYMPTOMS OF LOW BLOOD SUGARS, SWEATS, AND TREMBLING. THE PT ALSO CLAIMED THAT HE BECAME "HYPERGLYCEMIC" DUE TO THE ISSUE. AT 7 PM PST, THE PT WAS ADVISED OVER THE PHONE BY A HCP TO ADMINISTER 12 UNITS OF INSULIN. HE WAS NOT TESTED ON ANY OTHER DEVICE. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, TWO ADD'L CONTROL SOLUTION TESTS WERE PERFORMED AND THE RESULTS WERE WITHIN THE ACCEPTABLE RANGE (122, 126/102-137). REPLACEMENT PRODUCTS WERE SENT. THIS COMPLAINT IS BEING REPORTED AS REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION(S): WHILE THERE IS NO INDICATION THAT THE PRODUCT MALFUNCTIONED, BASED ON THE PASSING QUALITY CONTROL TESTS, THIS COMPLAINT IS BEING REPORTED BASED ON THE CUSTOMER'S ALLEGATION. THE PT ALLEGED DEVELOPING SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIC/HYPERGLYCEMIA AND RECEIVED HCP TREATMENT DUE TO THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2925271

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Life Threatening| R NA.